Safety-engineered phlebotomy devices

Joanna Ford PhD, SMTL - February 2008

Introduction

This report summarises the findings from an All Wales evaluation of 'safety' blood evacuation devices, completed in December 2007.

The evaluation process

The aim of the evaluation was to assess sharp safety blood evacuation devices available in the UK, in terms of device performance and user acceptability. It was a two stage process involving bench-top assessments/ functionality tests followed by work-place evaluations. The following section describes the process that was undertaken.

Requested samples of all 'safety' blood evacuation devices available in the UK at time of evaluation

Bench-top assessment of devices carried out by a group of health care professionals. Eleven devices assessed, three of them considered appropriate for All Wales evaluations.

Functionality tests carried out at SMTL. Included 'splatter test' where fluorescent liquid is drawn up into syringe and safety feature activated over paper to detect any splatter using UV light. Also, shield orientation test where devices with needle shields were prepared for use and the position of the shield in relation to the needle bevel was noted (i.e. some shield orientations make venipuncture difficult).

List of devices to be evaluated in Trusts finalised. They are the Becton Dickinson (BD) Eclipse (a needle shield), Greiner Quickshield (a needle shield) and the BD Pushbutton set (a retractable needle)

All Welsh NHS Trusts invited to participate in evaluations. One coordinator and approximately 5 users recruited from each participating Trust. Six hospitals in Wales and the Welsh Blood Service took part.

Device companies provided participants with devices and short training session prior to evaluations.

Evaluations commenced. Users performed usual tasks using the 'safety' devices instead of conventional devices where appropriate. A minimum of 10 devices were assessed by each user. Each user assessed each model of device in turn (order randomised by SMTL). User filled in a questionnaire after each model of device has been evaluated. Questionnaires designed by SMTL using a scoring system to evaluate device reliability, ease of activation etc

Once users evaluated all device models, they completed a questionnaire comparing the devices with each other

SMTL collated, analysed and presented data

Results were made available to provide advice and recommendations regarding future All Wales purchase contracts

Fig. 1. BD Eclipse with needle shield. During use the shield is above the needle bevel and following use the shield is pushed down and clicked into place, encasing needle.

Fig. 2. Greiner Quickshield with shield. During use the shield is to the side of the needle bevel (can be to the left or right) and following use the shield is pushed down and clicked into place, encasing needle.

Fig. 3. BD Pushbutton blood-taking set with wings and tubing. Following use, the white button on the casing is pushed down which retracts the needle into the device housing via a spring-loaded mechanism.

Results

1. Benchtop-assessment

All 11 devices assessed around a table by a group of experts before evaluations began. For blood collection needle devices possessing safety shields, it was clear how they were to be used and activated, and assessors found them fairly easy to operate. Most appeared to be easy to use with one hand. The blood collection 'sets' in the assessment possessing butterfly wings and tubing and were activated by a range of mechanisms. The safety feature was not considered to be very clear on most of the sets assessed and activation was not considered easy in most cases. The only set the assessors felt could be activated one-handed was the BD Pushbutton and so this was included in evaluations.

2. Laboratory tests

The BD Eclipse and Greiner Quickshield both possess needle shields and the consistency of shield orientation was assessed in the lab (it became clear that some of the shielded devices possessed shields which moved around or could be in different orientations upon opening of the pack which was not considered a desirable feature). The laboratory results showed that both the Eclipse and Quickshield had shields that were fixed in a particular orientation.

Device models selected for user evaluations underwent fluid-splatter testing. All 3 device models that were tested exhibited fluid splatter on some occasions. The Greiner Quickshield device performed the best out of the 3, only producing fluid-splatter on two occasions (10 %) compared with 8 occasions (40 %) for the BD Eclipse. The BD Pushbutton device produced splatter on 7 occasions (35 %) upon activation. In all cases, the fluid splatter was detected on the hand activating the retractable needle.

3. Evaluation results

33 users evaluated the Eclipse, 30 the Quickshield and 21 the Pushbutton. There were no striking differences between the results for the Eclipse and Quickshield evaluations and most users agree with the majority of statements on the form, indicating a relatively positive response. However, overall, the Eclipse product was favoured slightly more than the Quickshield.

The comparison questionnaire (see table IV) revealed that if users (n = 28) were asked to pick a favourite shielded needle, the majority of them chose the Eclipse. However, a smaller proportion of those who took part did favour the Quickshield over the Eclipse. One of the main reasons for this discrepancy appears to be whether users favour the shield above or to the side of the needle.

Fewer evaluations of the Pushbutton set were carried out (n = 21) than the other two devices because some Trusts stated that they either did not use sets to take blood or that they used very few. In general, results from the evaluations were more positive than had been anticipated from the bench-top assessment.

In terms of usability, more users appeared to be comfortable using the Eclipse than the Quickshield and in general, most users were more positive about the Eclipse. Most users found the Pushbutton set comfortable to use.

Discussion

The Eclipse and Quickshield possess needle shields which are clicked over the needle following use.

There are no striking differences between the results for the Eclipse and Quickshield evaluations and most users agree with the majority of statements on the form, indicating a relatively positive response. However, overall, the Eclipse product was favoured slightly more than the Quickshield.

Scores from the evaluation forms revealed that over 40% of the users felt that the Greiner shield interfered with use, whereas about 20% of users felt the same when using the Eclipse shield.

The comparison questionnaire revealed that if users were asked to pick a favourite, the majority of them chose the Eclipse (approximately 60%). However, as described previously, a smaller proportion of those who took part did favour the Quickshield over the Eclipse ( just over 35%). One of the main reasons for this discrepancy appears to be whether users favour the shield above (as the Eclipse) or to the side (as the Quickshield) of the needle. Different orientations appeared to interfere with different user procedures. Some user comments indicate that certain orientations make it uncomfortable for the user to hold the device and perform venipuncture whilst some bench-top assessors indicated that shields could visually obstruct the needle.

In conclusion, user acceptability was fairly similar between the two blood collection needles, but the Eclipse was the preferred device for most users in the evaluations. Placing the needle on the Greiner holder in the correct orientation to ensure the position of the shield represents an additional training step that does not exist with the Eclipse device. However, in fluid splatter tests the Quickshield performed better (splatter in 10% cases) than the Eclipse (splatter in 40% of cases) which indicates a potential infection risk.

During the preliminary bench-top assessments, the Pushbutton set was considered to be the only blood collection set assessed that could be activated easily with one hand. During the All Wales evaluations, the majority of users (approximately 85%) agreed that the Pushbutton could be activated using one hand.

Issues surrounding the use of 'safety' phlebotomy devices

Should any of the safety phlebotomy products be included on future purchase contracts, the compatibility of the devices with other products is an important consideration. For example, the tube holders and blood collection needles manufactured by different companies are not always compatible. Also, if there are problems with the devices, mixing devices from different companies could cause problems with responsibility and there may also be training issues when combined systems are used. If any new blood collection system was to be widely adopted throughout Wales, the issue of compatibility would obviously need to be addressed.

Conclusion

The evaluations did not reveal a clear favourite between the Eclipse and the Quickshield products but when compared with each other, the Eclipse was preferred by most of the users. Differences in opinion about the orientation of the shield meant that not all users preferred the same device. The Quickshield performed better in the fluid splatter tests that were performed in the laboratory beforehand.

Comments regarding the Pushbutton set were generally positive although a small number of users were unhappy using it and laboratory tests revealed that blood splash during activation is a concern. If any of these products were considered for future Welsh purchase contracts, compatibility with other blood taking products must be taken into consideration.

Acknowledgments

Our sincere thanks go to all Trust coordinators and users who took part in the evaluations. Without their efforts this project could not take place. We are also extremely grateful to all the companies for the provision of devices, in particular we would like to thank Becton Dickinson, Greiner Bio-One and Sarstedt for the provision of devices for evaluations and for the help and cooperation of their representatives who visited Trusts and trained users.